Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

December 20, 2025

Study Completion Date

September 20, 2028

Conditions
Peyronie's Disease
Interventions
DRUG

CCH administration

Patients will be randomized 3:1 into the CCH administration arm. After undergoing baseline assessments, this arm will receive up to 8 CCH injections, followed by final assessments 6 weeks later.

DRUG

Control - Crossover to CCH

Patients will be randomized 1:3 into the control arm. After undergoing baseline assessments, control men will not undergo treatments for 6 months. They will then have repeat assessments and receive up to 8 CCH injections. They will then have final assessments performed 6 weeks after treatment.

DEVICE

RestoreX

Both treatment arms will incorporate the use of RestoreX for 30-60 minutes daily during CCH administration and continued until 6 weeks after final injection administration.

Trial Locations (1)

84057

The Male Fertility and Peyronie's Clinic, Orem

All Listed Sponsors
lead

Charitable Union for the Research and Education of Peyronie's Disease

OTHER